FDA 483 - Denison Pharmaceuticals, LLC - April 05, 2016

Bestcon Pharmaceuticals, LLC, a drug manufacturer in Lincoln, RI, was cited for significant deficiencies in its quality control, laboratory operations, and facility maintenance during an FDA inspection. The firm failed to thoroughly investigate out-of-specification results, maintain data integrity, and ensure proper training and facility upkeep. These issues indicate a systemic lack of adherence to CGMP requirements.